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出境医 / 临床实验 / Controlled Exposure of Healthy Nonsmokers to Secondhand and Thirdhand Cigarette Smoke (THS04)

Controlled Exposure of Healthy Nonsmokers to Secondhand and Thirdhand Cigarette Smoke (THS04)

Study Description
Brief Summary:
This study compares the health effects of dermal and inhalational exposure to thirdhand cigarette smoke to those of inhalational exposure to secondhand cigarette smoke in healthy, adult nonsmokers. Our hypothesis is that dermal exposure increases exposure to the tobacco specific carcinogen, NNK and may affect both endothelial function and epidermal integrity.

Condition or disease Intervention/treatment Phase
Pollution; Exposure Smoke Inhalation Exposure to Pollution Other: Cigarette Smoke Other: Clean Air and Clean Clothing/Sham exposure Not Applicable

Detailed Description:

Thirdhand cigarette smoke is the smoke chemicals that persist in the environment after smoking. Indoors, they can be found both on surfaces and in the air. Thirdhand smoke derives from secondhand smoke and contains the chemicals that stick to surfaces, are re-emitted into the air and that form by chemical reactions both on surfaces and in the air.

Thirdhand smoke can contain higher concentrations of the tobacco-specific nitrosamine and known carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) than secondhand smoke, because nicotine reacts to form NNK in the indoor environment. Dermal exposure to thirdhand smoke includes nicotine, NNK and other tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, and volatile organic compounds. Inhalational exposure to thirdhand smoke includes nicotine, ultrafine particles and volatile organic compounds. Previous studies have shown that inhalational exposure to secondhand cigarette smoke causes endothelial dysfunction, which is a risk factor for heart disease and heart attacks.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Controlled Human Exposure and THS Generation Core
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Dermal Exposure to Thirdhand Cigarette Smoke
Participants will wear clothing that has been exposed to cigarette smoke, for 3 hours while breathing filtered, temperature and humidity controlled air.
 Other: Cigarette Smoke
Cigarette smoke, generated by a smoking machine and aged is used to reproduce exposure to secondhand and thirdhand cigarette smoke.
Active Comparator: Inhalational Exposure to Thirdhand Cigarette Smoke
Participants will breathe cigarette smoke aerosol that has been aged for 22 hours, for 3 hours while wearing clean clothing.
 Other: Cigarette Smoke
Cigarette smoke, generated by a smoking machine and aged is used to reproduce exposure to secondhand and thirdhand cigarette smoke.
Active Comparator: Inhalational Exposure to Secondhand Cigarette Smoke
Participants will breathe cigarette smoke aerosol that has been aged for 30 minutes, for 3 hours while wearing clean clothing.
 Other: Cigarette Smoke
Cigarette smoke, generated by a smoking machine and aged is used to reproduce exposure to secondhand and thirdhand cigarette smoke.
Sham Comparator: Clean Air Exposure
Participants will breathe filtered, temperature and humidity controlled air while wearing clean clothing for 3 hours.
 Other: Clean Air and Clean Clothing/Sham exposure

Clean air, created by high-efficiency particulate air (HEPA) and charcoal filtration and temperature and humidity control.

Clean cotton clothing.
Outcome Measures
Primary Outcome Measures :
  1. Changes in flow-mediated dilation (FMD) of the brachial artery, caused by pollution exposures, measured by ultrasound [ Time Frame: Baseline (before exposure) 30 minutes (after 30 minutes exposure) and 3 hours. ]
    High-resolution ultrasound of right brachial artery is performed 1 cm distal to antecubital fossa with a 10 megahertz (MHz) linear array probe coupled to a General Electric (GE) Vivid 7 Imaging System. To assess endothelium-dependent dilation, after recording baseline B-mode ultrasound images of the brachial artery and spectral Doppler images of flow velocity, a forearm cuff is inflated to 250 mmHg for 5 minutes to induce reactive hyperemia. Immediately after deflation, Doppler images are obtained to measure reactive hyperemia. FMD of brachial artery will be determined every 15 seconds between 30 and 120 seconds after cuff deflation to capture maximal dilation.The % FMD will be calculated as ratio between the maximum post cuff release brachial artery diameter and baseline diameter. By comparing changes in FMD before exposure, after exposure and next day, we will be able to assess effects of exposure on endothelial function and the potential recovery from these effects.


Secondary Outcome Measures :
  1. Changes in trans-epidermal water loss caused by pollution exposures, comparing intact skin to tape-stripped skin [ Time Frame: Baseline, 30 minutes, 3 hours, 2 days, 5 days ]
    We will measure trans-epidermal water loss (TEWL) on the volar forearm using a dermal relative humidity monitor (model IP52, Delfin Technologies Inc.) on adjacent circles of intact skin and skin that has been tape stripped prior to exposure. By comparing changes in TEWL at these two sites, before and after exposure and at day 2 and day 5, we will be able to detect any effects of dermal cigarette smoke exposure on skin barrier function and the rate of barrier function recovery.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy on the basis of medical history, blood pressure and test of C-reactive protein, lipids and blood sugar.
  • Non-smoker not exposed to second-hand smoke (SHS) as determined by saliva cotinine < 10 ng/ml and tetrahydrocannabinol (THC) < 50 ng/ml.
  • Flow mediated dilation of 4% or greater at screening visit.

Exclusion Criteria:

  • Age 18 < or > 50 Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma.

Unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications Systolic blood pressure > 150 Diastolic blood pressure > 100 Blood glucose > 110 LDL >130 Pregnancy or breastfeeding (by urine Human Chorionic Gonadotropin (hCG) and/or history) Alcohol or illicit drug dependence within the past 5 years BMI > 35 and < 18 Current illicit drug use (by history or urine test) More than 1 pack year smoking history Ever a daily marijuana smoker Smoked anything within the last 3 months Unable to hold allergy or other over-the-counter (OTC) medicines Occupational exposure to smoke, dusts and fumes Concurrent participation in another clinical trial Unable to communicate in English No social security number

Contacts and Locations

Contacts
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Contact: Suzaynn F Schick, PhD 628-206-5904 suzaynn.schick@ucsf.edu
Contact: Abel Huang, BA 415-6286685 abel.huang@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Abel Huang       Abel.Huang@ucsf.edu   
Principal Investigator: Suzyann Schick, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Suzaynn F Schick, PhD University of California, San Francisco
Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date June 22, 2020
Actual Study Start Date  ICMJE January 20, 2020
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2020) 		Changes in flow-mediated dilation (FMD) of the brachial artery, caused by pollution exposures, measured by ultrasound [ Time Frame: Baseline (before exposure) 30 minutes (after 30 minutes exposure) and 3 hours. ]
High-resolution ultrasound of right brachial artery is performed 1 cm distal to antecubital fossa with a 10 megahertz (MHz) linear array probe coupled to a General Electric (GE) Vivid 7 Imaging System. To assess endothelium-dependent dilation, after recording baseline B-mode ultrasound images of the brachial artery and spectral Doppler images of flow velocity, a forearm cuff is inflated to 250 mmHg for 5 minutes to induce reactive hyperemia. Immediately after deflation, Doppler images are obtained to measure reactive hyperemia. FMD of brachial artery will be determined every 15 seconds between 30 and 120 seconds after cuff deflation to capture maximal dilation.The % FMD will be calculated as ratio between the maximum post cuff release brachial artery diameter and baseline diameter. By comparing changes in FMD before exposure, after exposure and next day, we will be able to assess effects of exposure on endothelial function and the potential recovery from these effects.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Changes in flow-mediated dilation of the brachial artery, caused by pollution exposures, measured by ultrasound [ Time Frame: Baseline (before exposure) 30 minutes (after 30 minutes exposure) and 3 hours. ]
High-resolution ultrasound of the right brachial artery is performed 1 cm distal to the antecubital fossa with a 10MHz linear array probe coupled to a GE Vivid 7 Imaging System. To assess endothelium-dependent dilation, after recording baseline B-mode ultrasound images of the brachial artery and spectral Doppler images of flow velocity, a forearm cuff is inflated to 250 mmHg for 5 minutes to induce reactive hyperemia. Immediately after deflation, Doppler images are obtained to measure reactive hyperemia. FMD of the brachial artery will be determined every 15 seconds between 30 and 120 seconds after cuff deflation to capture maximal dilation.The % FMD will be calculated as the ratio between the maximum post cuff release brachial artery diameter and the baseline diameter. By comparing changes in FMD before exposure, after exposure and the next day, we will be able to assess the effects of exposure on endothelial function and the potential recovery from these effects.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Changes in trans-epidermal water loss caused by pollution exposures, comparing intact skin to tape-stripped skin [ Time Frame: Baseline, 30 minutes, 3 hours, 2 days, 5 days ]
We will measure trans-epidermal water loss (TEWL) on the volar forearm using a dermal relative humidity monitor (model IP52, Delfin Technologies Inc.) on adjacent circles of intact skin and skin that has been tape stripped prior to exposure. By comparing changes in TEWL at these two sites, before and after exposure and at day 2 and day 5, we will be able to detect any effects of dermal cigarette smoke exposure on skin barrier function and the rate of barrier function recovery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Controlled Exposure of Healthy Nonsmokers to Secondhand and Thirdhand Cigarette Smoke
Official Title  ICMJE Controlled Human Exposure and THS Generation Core
Brief Summary This study compares the health effects of dermal and inhalational exposure to thirdhand cigarette smoke to those of inhalational exposure to secondhand cigarette smoke in healthy, adult nonsmokers. Our hypothesis is that dermal exposure increases exposure to the tobacco specific carcinogen, NNK and may affect both endothelial function and epidermal integrity.
Detailed Description

Thirdhand cigarette smoke is the smoke chemicals that persist in the environment after smoking. Indoors, they can be found both on surfaces and in the air. Thirdhand smoke derives from secondhand smoke and contains the chemicals that stick to surfaces, are re-emitted into the air and that form by chemical reactions both on surfaces and in the air.

Thirdhand smoke can contain higher concentrations of the tobacco-specific nitrosamine and known carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) than secondhand smoke, because nicotine reacts to form NNK in the indoor environment. Dermal exposure to thirdhand smoke includes nicotine, NNK and other tobacco-specific nitrosamines, polycyclic aromatic hydrocarbons, and volatile organic compounds. Inhalational exposure to thirdhand smoke includes nicotine, ultrafine particles and volatile organic compounds. Previous studies have shown that inhalational exposure to secondhand cigarette smoke causes endothelial dysfunction, which is a risk factor for heart disease and heart attacks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Pollution; Exposure
  • Smoke Inhalation
  • Exposure to Pollution
Intervention  ICMJE
  • Other: Cigarette Smoke
    Cigarette smoke, generated by a smoking machine and aged is used to reproduce exposure to secondhand and thirdhand cigarette smoke.
  • Other: Clean Air and Clean Clothing/Sham exposure

    Clean air, created by high-efficiency particulate air (HEPA) and charcoal filtration and temperature and humidity control.

    Clean cotton clothing.
Study Arms  ICMJE
  • Experimental: Dermal Exposure to Thirdhand Cigarette Smoke
    Participants will wear clothing that has been exposed to cigarette smoke, for 3 hours while breathing filtered, temperature and humidity controlled air.
    Intervention: Other: Cigarette Smoke
  • Active Comparator: Inhalational Exposure to Thirdhand Cigarette Smoke
    Participants will breathe cigarette smoke aerosol that has been aged for 22 hours, for 3 hours while wearing clean clothing.
    Intervention: Other: Cigarette Smoke
  • Active Comparator: Inhalational Exposure to Secondhand Cigarette Smoke
    Participants will breathe cigarette smoke aerosol that has been aged for 30 minutes, for 3 hours while wearing clean clothing.
    Intervention: Other: Cigarette Smoke
  • Sham Comparator: Clean Air Exposure
    Participants will breathe filtered, temperature and humidity controlled air while wearing clean clothing for 3 hours.
    Intervention: Other: Clean Air and Clean Clothing/Sham exposure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2023
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy on the basis of medical history, blood pressure and test of C-reactive protein, lipids and blood sugar.
  • Non-smoker not exposed to second-hand smoke (SHS) as determined by saliva cotinine < 10 ng/ml and tetrahydrocannabinol (THC) < 50 ng/ml.
  • Flow mediated dilation of 4% or greater at screening visit.

Exclusion Criteria:

  • Age 18 < or > 50 Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma.

Unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications Systolic blood pressure > 150 Diastolic blood pressure > 100 Blood glucose > 110 LDL >130 Pregnancy or breastfeeding (by urine Human Chorionic Gonadotropin (hCG) and/or history) Alcohol or illicit drug dependence within the past 5 years BMI > 35 and < 18 Current illicit drug use (by history or urine test) More than 1 pack year smoking history Ever a daily marijuana smoker Smoked anything within the last 3 months Unable to hold allergy or other over-the-counter (OTC) medicines Occupational exposure to smoke, dusts and fumes Concurrent participation in another clinical trial Unable to communicate in English No social security number
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Suzaynn F Schick, PhD 628-206-5904 suzaynn.schick@ucsf.edu
Contact: Abel Huang, BA 415-6286685 abel.huang@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013256
Other Study ID Numbers  ICMJE 28PT-0081
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We will share the individual participant data (IPD) that underlie the results in our publications.
Supporting Materials: Study Protocol
Time Frame: 9 months after publication
Access Criteria: Data will be made available to researchers who submit a detailed and well-supported description of their research plans.
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suzaynn F Schick, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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